It would be hard to overstate the excitement scientists at UW-Madison and elsewhere felt when President Barack Obama signed an executive order lifting restrictions on taxpayer-funded research using human embryonic stem cells.
Among those in attendance at the White House on March 9, 2009 for the president's announcement were Jamie Thomson, UW-Madison's world-renowned stem cell pioneer, and Clive Svendsen, then the co-director of UW-Madison's Stem Cell and Regenerative Medicine Center.
"It was one of the most exciting moments of my life, and Jamie said the same thing," Svendsen, who left UW-Madison Dec. 1 to direct a new institute in Los Angeles, told the Cap Times last year.
Thomson, who was the first to isolate human embryonic stem cells in 1998, released a statement that noted: "The executive action by President Obama lifting restrictions on federal funding for human embryonic stem cell research is a welcome milestone for our field. The decision will help restore America as a leader in this field and is a clear path out of a policy thicket that has slowed the pace of discovery for eight years."
But a year later much of that excitement has been replaced by hand-wringing, with many scientists complaining that Obama's new stem cell policy is creating new barriers and jeopardizing years of experimentation.
"I think ‘frustration' is a good word to describe it," Carl Gulbrandsen, managing director of the Wisconsin Alumni Research Foundation, said during a break in Wednesday's Wisconsin Stem Cell Symposium at the BioPharmaceutical Technology Center. WARF, which moves inventions at UW-Madison from the lab to the marketplace, owns intellectual property rights in several human embryonic stem cell lines.
There's no doubt there's been a "loss of momentum" in the field, Derek Hei, the director of UW-Madison's Waisman Clinical BioManufacturing Facility, told conference-goers.
Although Obama's stem cell policy opened the door for federal funding of more stem cell lines using human embryos, researchers are facing an unexpected setback: Most of the stem cell lines that could be studied using taxpayer funds under George W. Bush are currently off limits. In the middle of this controversy are a handful of popular embryonic stem cell lines owned by WiCell, a nonprofit research institute and private support organization of UW-Madison that advances stem cell science.
In fact, the three most-used lines during the Bush era -- H1, H7 and H9 -- belong to WiCell. To date, however, only the H1 line has been given the green light for current use. That's because the H7 and H9 lines were derived from embryos in Israel, and Gulbrandsen says that has made it difficult to track down and forward the necessary paperwork to the National Institutes of Health, which has implemented stringent new guidelines to ensure that all lines used by researchers were derived in a responsible, ethical manner. Gulbrandsen says it not only took a good deal of effort to track down the 10-year-old consent forms and other documents from the Rambam Medical Center in Haifa, but the paperwork then had to be translated from Hebrew to English.
"So it wasn't a simple process and now you have these unintended consequences of these lines not being available," says Gulbrandsen.
Gulbrandsen says he has no ethical concerns with these lines.
"Frankly, I think this whole process is kind of arbitrary," he says. "To suggest you now have to go through a process and follow guidelines that weren't in existence at the time these were approved doesn't make a lot of sense. There is nothing that makes these older lines any more or less ethical than the current ones. It's purely bureaucratic."
The good news is that the H7 and H9 lines were finally submitted to the NIH for review on April 13. It is not clear, however, how long that review process will take, and until the lines are officially approved many who study stem cells will be holding their breath.
"Those WiCell lines have become the gold standard of the science," says Hei. "If you lose those, it would be like pulling the rug out from underneath us and losing years of research."
For the previous eight years, scientists using federal dollars to study human embryonic stem cells had to restrict their research to the 21 cell lines approved by the National Institutes of Health prior to August 2001. That's when Bush, siding with social conservatives and anti-abortion groups who were outraged that human embryos were destroyed to make stem cell lines, issued a directive limiting research to the lines created prior to that date.
Obama lifted the Bush restrictions with his executive order in March 2009, then left it up to the NIH to draft a set of ethical guidelines determining what would be allowed in stem cell research. In July, the NIH released these new guidelines, which stipulate new lines must be derived from cells obtained from fertility clinic embryos that otherwise would have been discarded. Additionally, these embryos must come with the documented "informed consent" of the parents or mother.
Those who received grants to work on stem cells prior to July of 2009 can still use all the Bush era lines. But moving forward, the NIH is starting a new registry of qualified lines. Each new stem cell line will be approved -- or denied -- following a case-by-case evaluation. To date, 50 new lines have been approved by the NIH and another 113 are pending review, according to NIH spokesperson Don Ralbovsky.
But the fact that only one of the Bush era lines, H1, has been approved for the new registry is frustrating many researchers.
Tim Kamp, director of UW-Madison's Stem Cell and Regenerative Medicine Center, wishes the NIH had "grandfathered" these older lines into the new registry -- or at least instituted a grace period so these lines could still have been used while the NIH was determining if they met the new standards.
"I don't disagree with the logic of wanting to reexamine these older cell lines," says Kamp. "None of us want to use tainted cell lines that aren't ethically derived. I just wish the administration of this new policy would have been handled differently."
